Life sciences industry groups ask for indefinite stay, say FDA strayed

The Final rule titled Clarification of When Products Made or Derived From Tobacco Are Regulated As Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” (82 FR 2193, January 9, 2017) violates the Administrative Procedures Act (APA) (P.L. 79-404) and constitutes an overstep of the FDA’s authority, according to a petition for an indefinite stay of the rule’s implementation, filed by the industry groups, Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO). The petition focuses primarily on the second part of the Final rule, asking the FDA to indefinitely halt implementation of the Final rule’s new “intended use” policy.

Petition

The petition asserts, by not adequately informing the public of changes to the “intended use” doctrine, the FDA’s final rule violates the APA.  The substance of the petition argues by not including the “intended use” changes prior to the publication of the Final rule, on January 9, 2017, the industry groups were deprived of the fair notice and hearing required by the APA. Instead of being a permissible “logical outgrowth” of the proposed rule, the industry groups assert that the FDA strayed too far beyond the Proposed rule (80 FR 57756) and engaged in “a fundamental change to the regulatory scheme for drugs and devices.”

Intended use

Section 502(f)(1) of the Food, Drug, and Cosmetics Act (FDC Act) requires that drug and device labeling contains “adequate information” regarding any “use for which [the drug or device] is intended.” The doctrine was codified at 21 C.F.R. Sec. 201.128 (for drugs) and at 21 C.F.R. Sec. 801.4 (for medical devices). The FDA doctrine includes the following provision: “if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug or device introduced into interstate commerce by him is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug which accords with such other uses to which the article is to be put.”

The petitioners object to the above, the FDA’s pre-rule regulatory position, and were, instead, supportive of the position set out in the Proposed rule, which would have established a position where the FDA would no longer “regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm’s knowledge that such product was being prescribed or used by doctors for such use.”

Totality of the evidence

The industry groups challenge what they call the totality of the evidence standard, which, they say, the FDA presented for the first time in the Final rule, a doctrine under which a manufacturer would be required to provide adequate labeling for all intended uses, if the “totality of the evidence” indicates the manufacturer intends for a drug to have off-label uses. The petition asserts that by establishing such a requirement, the Final rule will violate the First Amendment to the U.S. Constitution, chilling truthful and non-misleading promotional speech.

Review

The petition is currently under FDA review. There are currently no pending resolutions to disapprove the rule in Congress.

 

FTC sets enforcement policy for homeopathic drug labeling claims

Efficacy and safety claims made on over the counter (OTC) homeopathic drug labeling must be substantiated by reliable scientific evidence, according to an enforcement policy statement on the marketing of OTC homeopathic drugs released by the Federal Trade Commission (FTC). The policy statement notes that qualified efficacy and safety claims must clearly indicate: (1) there is no scientific evidence that the product works and (2) the product’s claims are based only on theories of homeopathy from the 1700s that are not accepted by most modern medical experts. The policy statement indicates that the FTC will enforce OTC homeopathic drug labeling no differently than it does any other health products.

Homeopathy

The homeopathic theory is premised on the belief that disease can be treated by small doses of substances, which, in larger doses, produce in healthy individuals, symptoms similar to the disease. However, homeopathic products are often diluted so that the “therapeutic” substance is below a detectable level. Homeopathic theory states the more a substance is diluted, the more potent it becomes. The theory is not accepted by most modern medical experts. As a result, marketing claims for homeopathic remedies have a tendency to be misleading, in violation of federal law.

Enforcement

Section 5 of the Federal Trade Commission Act (FTC Act) (15 U.S.C. § 45(a)(2)), which applies to both advertising and labeling, prohibits unfair or deceptive acts or practices in or affecting commerce, such as the deceptive advertising or labeling of OTC drugs. Due to the significant expansion of the homeopathic industry over the last few decades—growth from a multimillion-dollar market to a more than billion-dollar market—the FTC held a workshop in 2015 to better comprehend the homeopathic marketplace. The workshop was focused on assisting the agency with understanding its legal authority with respect to the advertising and marketing of OTC homeopathic drugs.

Disclosures

The policy statement notes that disclosures regarding the absence of scientific evidence should be prominent and in close proximity to any statement about the product’s efficacy. Depending upon the strength of the efficacy statement, the FTC indicated that the disclosure might need to be incorporated into the efficacy message, itself. Additionally, the policy statement warns marketers of homeopathic drugs not to make statements which undercut those disclosures because the FTC will scrutinize the “net impression” of OTC homeopathic marketing claims when determining whether a marketer has violated the FTC Act.

 

FDA wants to know how you define “healthy”

The FDA wants to know how consumers view and use the Nutrition Facts label while purchasing foods; so much so that it is taking steps seeking public input on how the claim “healthy” is used on food packages. Noting that there are various terms on food packages such as “healthy,” “low in fat,”or “good source,” the FDA recognized that many consumers do not have the time to consider the details of nutrition information on every package purchased. In fact, most purchase decisions are made quickly, within three to five seconds.

The agency’s interest extends to questions such as: (1) what current dietary recommendations should be reflected in the definition of “healthy;” (2) what are the public health benefits of defining the term “healthy;” (3) what do consumers expect of foods that carry a “healthy” claim; and (4) what factors and criteria should be used for the new definition of “healthy.” Future public forums will explore these topics. The FDA will also begin the process of evaluating other label claims in order to modernize food labels in a manner that consumers find useful.

The public input is in part due to concerns that food manufacturers were not complying with requirements permitting content claims. In 2015, the FDA issued a warning letter to Kind, saying the food manufacturer could not claim its fruit and nut bars were healthy because they contained too much saturated fat and because it described the antioxidant content as healthy despite no medical definition to back up the claim. Following receipt of the closeout letter, Kind requested confirmation that it could use the phrase “healthy and tasty” only in text referencing its corporate policy. The FDA did not object, as long as Kind did not use those terms on the same display panel as nutrient content claims or nutrition information.

While the FDA is considering how to redefine the term “healthy” as a nutrient content claim, food manufacturers can continue to use the term “healthy” on foods that meet the current regulatory definition as the agency does not intend to enforce the regulatory requirements for products that use the term if certain criteria described in a newly published guidance document are met.

 

An impossible course: navigating the generic drug label delay

In May 2016, the FDA put off until 2017 a decision about a Final rule that would allow generic drug companies to update their labels with new safety information similar to their reference product counterparts. This marks the third time since the FDA proposed the rule that it has been shelved in the face of opposition from the pharmaceutical industry and some lawmakers. The delay, with major ramifications for consumers and industry alike, was initially discovered in an update to a timetable for the rule and officially appeared in a Federal Register Notice in mid-June. The development dismayed consumer groups and representatives for trial lawyers, who had urged the agency to close a legal loophole that prevents patients harmed by generic drugs from suing manufacturers.

Unlike brand-name drug makers, generic drug makers are not permitted to make changes to a drug’s label without the FDA’s approval unless the brand name drug maker makes the label change first. Instead, generic drug makers must wait for the FDA to order them to change their label. Since the passage of the Drug Price Competition and Patent Term Restoration Act (P.L. 98-417) in 1984, known as the Hatch-Waxman Act, the FDA has approved over 8,000 generic drugs. The Hatch-Waxman Act provides an expedited approval process for generic drugs that have an identical reference listed drug (RLD). As a result, nearly nine in 10 prescriptions filled today in the U.S. are for generic drugs, yet only account for 28 percent of drug expenditures.

Two Supreme Court decisions have helped to establish the conflicting division faced by patients and drug makers regarding drug label. Under the federal Food, Drug, and Cosmetic Act (FDC Act) and the subsequent Hatch-Waxman Act amendments, a generic drug company “may not unilaterally change its labeling or change its design or formulation and cannot be required to exit the market or accept state tort liability.” Consequently, a state law is preempted in the event a generic drug manufacturer must take one of the aforementioned actions to comply with a state law duty. Thus, patients taking a generic prescription drug are unable to recover for alleged injuries from either the brand name or generic drug maker. The brand name drug maker is not liable because it did not sell the drug directly to the patient and the generic drug maker faces the “impossibility” of providing updates to the drug label without direction from the brand name drug maker.

This White Paper provides an overview of the laws and regulations establishing the foundation of drug labels. The White Paper will also discuss the impact of the Supreme Court decisions on consumers’ ability to sue a drug maker for its drug labels. Finally, this White Paper examines whether industry pressure or consumer sentiment will carry the day. As the public service announcement from the FDA attests, it may be difficult to get generic drug approval, but as follows in this White Paper, generic drug makers are also harder to sue.

Read further: “An impossible course: navigating the generic drug label delay.”